Phase 2/Phase 3 Study To Evaluate The Efficacy And Safety Of Ramatroban Along With The Standard Of Care In Subjects Hospitalized For COVID Pneumonia

Summary

Phase II/Phase III study to evaluate the safety and efficacy of Ramatroban 75 mg tablet against Placebo in subjects hospitalized for pneumonia due to SARS-CoV-2 infection.

Approximately 324 eligible subjects will be randomized in a 1:1 ratio to one of the two treatment groups.

Group I: Ramatroban 75 mg tablet + Standard of care; Group II: Placebo + Standard of care.

Phase 2

Primary Objective:

To evaluate the safety of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects.

Secondary Objective:

To assess the efficacy of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects.

Phase 3

Primary Objective:

To evaluate the efficacy of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects.

Secondary Objective:

To evaluate the safety of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects.

Long COVID \[Follow-up Phase- Objectives- (Phase 2 \& 3)\]

1. To examine lipid mediators, specifically thromboxane A2, prostaglandin D2, F2-isoprostane and/or their metabolites in convalescent subjects after treatment.
2. To assess the efficacy of Ramatroban administered during the acute illness in preventing/mitigating subsequent development of long COVID / PASC

Conditions

• COVID-19 Pneumonia
• COVID-19 Respiratory Infection

Interventions

DRUG

Ramatroban

Route of Administration: Oral Dose: 75 mg; Frequency: Twice daily; Total duration of intervention: 28 days. Subjects will be evaluated over a study period of approximately 365 days.

DRUG

Placebo

Matching placebo will be administered orally twice a day

Sponsors & Collaborators

• JSS Medical Research Inc.

  collaborator INDUSTRY

• Biomedical Advanced Research and Development Authority

  collaborator FED

• Open Philanthropy

  collaborator OTHER

• Charak Laboratories India Pvt. Ltd

  collaborator UNKNOWN

• Charak Foundation

  collaborator UNKNOWN

• BioLink Life Sciences, Inc.

  collaborator INDUSTRY

• KARE Biosciences

  lead INDUSTRY

Principal Investigators

• Ajay Gupta, MD · KARE Biosciences

• Martin Ogletree, PhD · Points & Assists, LLC.

• Deanna J Nelson, PhD · BioLink Life Sciences, Inc.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-11-10

Primary Completion

2024-07-01

Completion

2026-05-31

Countries

• India

Study Locations